• Responsible for assessing, evaluating, and reviewing corporate operations against GCP regulations to assure real-time observation of activities, issue identification/ resolution, including proper and timely documentation • Facilitates and conducts internal and external audits and provides metrics and analysisof trends based on audit findings • Assist in the conduct or arrangement of GCP training for all staff • Maintain the Controlled Document and Training systems and oversee administrative support utilized in maintaining systems • Manage process and tracks controlled documents from the Document Change Control Form (DCRF) process until document approval or retirement, including updating related Controlled Document, training logs, and trackers • Responsible for providing quality oversight to the revision, review, and approval of controlled documents • Work with document reviewers to advise and revise controlled documents as appropriate and ensure reviews are performed in a timely manner • Responsible for providing input and support as appropriate to the creation of new controlled documents • Works with QA Management and other departments to identify gaps in controlled documents and recommends solutions • Communicate effectively with staff and management across departments on status of Controlled Documents and corporate training • Participate in inspection readiness activities and corporate audits, sponsor audits and/or regulatory inspections, as required • Works closely with others to determine root cause and potential preventive/corrective actions in support of the corporate CAPA Program. Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations. Ensure support for the timely closure of investigations • Assist QA management with the evaluation of learning management systems and other QA technology, as required • Assist in the preparation of quality metrics and reports • Assist QA management team with other Clinical QA activities as required • Other duties, as assigned